Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal ca

FDA device recall Z-1453-2014 · posted 2014-04-16 · Terminated

Recall details

Recalling firm

Micro Therapeutics Inc, Dba Ev3 Neurovascular

Reason for recall

Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.

Action taken

A customer notification letter was sent on 4/1/14 to all customers who purchased the Pipeline Embolization Device and the Alligator Retrieval Device. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the customer response form and fax the completed form to Covidien at (763) 591-3519. Customers with questions are instructed to contact Dr. Mark A. Turco at (202) 310-5120. A press release was sent on 4/11/14 to Business Wire Newsroom to inform the public about the recall from Covidien. The recall is regarding certain lots of its Pipeline Embolization Device and Alligator Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate adn detach from the devices. Consumers are instructed to report any adverse reactions or quality problems experienced with the use of the product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Consumers with may also contact Covidien Customer Service at (800) 716-6700 between 7am to 7pm (central) or email at customerserviceus@covidien.com.

Root cause

Process change control

Status

Terminated

Product code

DQY

Quantity affected

32 units total (23 units in US)

Distribution

Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, It

Date initiated

2014-04-01

Date posted

2014-04-16

Date terminated

2014-10-31

Location

Irvine, CA